Identity
- Trade Name
- HAderm EUDAMED
- Device Name
- Medical Cross-linked Sodium Hyaluronate Gel-Soft Tissue Filler EUDAMED
- Model / Reference
- Sub Skin (2.0ml, HAderm®) EUDAMED01-02-19 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974656020528 EUDAMED
- Basic UDI-DI
- B-06974656020528 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
HAderm by Shanghai Reyoungel Medical Technology Company Limited — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06974656020528 | Class III | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000010507
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 4df7c674-6231-4796-b49a-dc70deaa6ce4 61 fields · synced Oct 6, 2026